New Basal Insulin Granted Tentative FDA Approval

New Basal Insulin Granted Tentative FDA Approval
New Basal Insulin Granted Tentative FDA Approval

The Food and Drug Administration (FDA) has granted tentative approval for Basaglar (insulin glargine injection; Boehringer Ingelheim and Lilly) to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes.

Basaglar contains the same amino acid sequence as the currently available insulin glargine product, and has been tentatively approved for use with the prefilled dosing device, KwikPen.

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The tentative approval indicates that the FDA has determined Basaglar meets all the regulatory requirements for approval but it is subject to a stay of up to 30 months due to a litigation filed by Sanofi claiming patent infringement. The final FDA approval has to come at the end of the 30-month period in mid-2016 unless the court finds Lilly in favor earlier.

For more information visit Boehringer-Ingelheim.com or Lilly.com.

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